NCT00001418

Brief Summary

This study is designed to use PET scans in order to measure activity of the sympathetic nervous system. The sympathetic nervous system is the portion of the nervous system that maintains a normal supply of blood and fuel to organs during stressful situations. PET scan or Positron Emission Tomography is an advanced form of an X-ray. It is used to detect radioactive substances in the body. During this study researchers plan to inject small amounts of the radioactive drug fluorodopamine into patients. Fluorodopamine is very similar to the chemicals found in the sympathetic nervous system. It can attach to sympathetic nerve endings and allow researchers to view them with the aid of a PET scan. One area of the body with many sympathetic nerve endings is the heart. After giving a dose of fluorodopamine, researchers will be able to visualize all of the sympathetic nerve endings involved in the activity of the heart. In addition, this diagnostic test will help researchers detect abnormalities of the nervous system of patient's hearts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1994

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Sympathetic Nervous SystemDysautonomiasPostural Tachycardia SyndromeNeurocardiogenic SyncopeHypernoradrenergic HypertensionSympathectomyFluorodopaminePositron Emission TomographyNorepinephrineDopamineNeurocardiologic Disorder

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The subjects are adult patients in one of the following diagnostic categories: coronary heart disease or chest pain and normal coronary arteries; myocardial dysfunction or failure; hypertension; or dysautonomia. Groups of appropriately matched healthy volunteers are studied concurrently as controls.

You may not qualify if:

  • Minors are excluded.
  • Subjects in whom anatomic factors complicate vascular access are excluded.
  • Subjects who are not expected clinically to tolerate recumbency during the procedures are excluded.
  • Pregnant or lactating women are excluded.
  • Cardiology patients may be tested while off their usual medications. In this situation, the patients will be inpatients on the cardiology ward, managed clinically by staff of the Cardiology Branch, DIR, NHLBI. Hypertensives will be tested afer having discontinued anti-hypertensive medications for up to two weeks.
  • Patients who must take medications continually in the following categories are excluded: anticoagulants, tricyclic antidepressants, barbiturates, aspirin, acetaminophen.
  • Patients unable to discontinue nicotine or alcohol temporarily are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Autonomic Nervous System DiseasesPostural Orthostatic Tachycardia SyndromeSyncope, Vasovagal

Condition Hierarchy (Ancestors)

Nervous System DiseasesOrthostatic IntolerancePrimary DysautonomiasSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1994

Study Completion

August 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-08

Locations